RecruitingPhase 3NCT04066764

Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters

An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

200 participants

Start Date

May 8, 2020

Study Type

INTERVENTIONAL

Conditions

Venous Thromboembolism

Summary

The purpose of this study is to evaluate the efficacy and safety of new oral anticoagulants and vitamin K antagonists for the anticoagulation for the implantation of vena cava filters in patients with deep venous thrombosis.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.

Exclusion Criteria14

Age < 18 years or age > 75 years,
With obvious contraindications for anticoagulation therapy,
Allergic to iodine contrast agents in the past,
Pregnant or breastfeeding women,
With malignant tumors and life expectancy < 1 year,
Severe liver diseases (such as acute hepatitis, chronic active hepatitis or cirrhosis) or alanine aminotransferase levels were higher than three times the upper limit of normal.
With other diseases that need anticoagulation,
With previous heparin-induced thrombocytopenia,
Bacterial endocarditis,
Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg,
Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers
With severe renal insufficiency (creatinine clearance <30 mL/min)
Allergic to the drug used in this study
With permanent filter implantation

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Interventions

DRUGRivaroxaban

15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral

DRUGWarfarin

3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral

DRUGNadroparin

Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous